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Interventions to increase enrollment in a large multicenter phase 3 trial of carotid stenting vs. endarterectomy

Authors


  • This work was done by JNR while at Mayo Clinic in Jacksonville, FL, and does not represent the official position of the National Institutes of Health/National Institute of Neurological Disorders and Stroke.
  • Conflict of interest: The authors declare that there is no conflict of interest.
  • Funding: This work was supported by the National Institute of Neurological Disorders and Stroke and the National Institutes of Health (R01 NS 038384); supplemental funding from Abbott Vascular Solutions, Inc. (formerly Guidant).
  • Clinical Trial Registration Information: ClinicalTrials.gov Web site identifier: NCT0000473

Correspondence: Thomas G. Brott, Mayo Clinic, Griffin Building 3rd Floor, 4500 San Pablo Rd, Jacksonville, FL 32224, USA.

E-mail: brott.thomas@mayo.edu

Abstract

Background

Randomized clinical trials often encounter slow enrollment. Failing to meet sample size requirements has scientific, financial, and ethical implications.

Aims

We report interventions used to accelerate recruitment in a large multicenter clinical trial that was not meeting prespecified enrollment commitments.

Methods

The Carotid Revascularization Endarterectomy vs. Stenting Trial began randomization in December 2000. To accelerate enrollment, multiple recruitment tactics were initiated, which included expanding the number of sites, hiring a recruitment director (May 2003), broadening eligibility criteria (April 2005), branding with a study logo, Web site, and recruitment materials, increasing site visits by study leadership, sending e-mails to the site teams after every enrollment, distributing electronic newsletters, and implementing investigator and coordinator conferences.

Results

From December 2000 through May 2003, 14 sites became active (54 patients randomized), from June 2003 through April 2005, 44 sites were added (404 patients randomized), and from May 2005 through July 2008, 54 sites were added (2044 patients randomized). During these time intervals, the number of patients enrolled per site per year was 1·5, 3·6, and 5·6. For the single years 2004 to 2008, the mean monthly randomization rates per year were 19·7, 38·1, 56·4, 53·0, and 54·7 (annualized), respectively. Enrollment was highest after recruitment tactics were implemented: 677 patients in 2006, 636 in 2007, and 657 in 2008 (annualized). The prespecified sample size of 2502 patients, 47% asymptomatic, was accomplished on July 2008.

Conclusions

Aggressive recruitment tactics and investment in a full-time recruitment director who can lead implementation may be effective in accelerating recruitment in multicenter trials.

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